search
Back to results

Prediction of Outcomes Following Total Knee Replacement- Pilot (POKR-p)

Primary Purpose

Osteoarthritis, Knee, Knee Replacement

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based Cognitive Behavioral Therapy
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis, Knee focused on measuring CBT

Eligibility Criteria

45 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 45 or older,
  2. Meet the American College of Rheumatology criteria for knee OA,
  3. Scheduled to undergo total knee arthroplasty,
  4. Facility with the English language that is adequate to complete study procedures

Exclusion Criteria:

  1. Cognitive impairment preventing completion of study assessment procedures.
  2. Myocardial infarction within the past 12 months.
  3. Presence of Severe Raynaud's or severe neuropathy,
  4. Active vasculitis or severe peripheral vascular disease,
  5. Current infection,
  6. Use of oral steroids,
  7. Recent history of substance abuse or dependence,
  8. Known anemia

Sites / Locations

  • Brigham and Women's Hospital Pain Management Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness-based CBT

Treatment as Usual

Arm Description

All participants will receive four individual mindfulness-based CBT sessions.

All participants will undergo surgery as usual, with no additional intervention.

Outcomes

Primary Outcome Measures

Brief Pain Inventory (BPI)
Measure of pain severity and pain interference
Brief Pain Inventory (BPI)
Measure of pain severity and pain interference
Brief Pain Inventory (BPI)
Measure of pain severity and pain interference
Brief Pain Inventory (BPI)
Measure of pain severity and pain interference

Secondary Outcome Measures

Quantitative Sensory Testing (QST)
Measures of responses to standardized stimuli
Quantitative Sensory Testing (QST)
Measures of responses to standardized stimuli
Pain Catastrophizing Scale
Assess catastrophic thinking related to pain
Pain Catastrophizing Scale
Assess catastrophic thinking related to pain
Pain Catastrophizing Scale
Assess catastrophic thinking related to pain
Pain Catastrophizing Scale
Assess catastrophic thinking related to pain
PROMIS-SF
Measures anxiety and depression symptoms
PROMIS-SF
Measures anxiety and depression symptoms
PROMIS-SF
Measures anxiety and depression symptoms
PROMIS-SF
Measures anxiety and depression symptoms
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.

Full Information

First Posted
February 3, 2020
Last Updated
February 8, 2023
Sponsor
Brigham and Women's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04328701
Brief Title
Prediction of Outcomes Following Total Knee Replacement- Pilot
Acronym
POKR-p
Official Title
Prediction of Outcomes Following Total Knee Replacement- Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study seeks to examine multiple risk factors as predictors of pain and function following total knee arthroplasty (TKA). Risk factors will be measured pre-surgically using psychophysical testing procedures, multimodal evaluation of sleep, standardized questionnaires. Additionally, this study will collect pilot data on a brief mindfulness-based cognitive-behavioral treatment that may help to improve long-term TKA outcomes. The pilot study compared TKA patients that received brief mindfulness-based cognitive behavioral therapy (MBCBT) to the treatment-as-usual (TAU) group from the parent study.
Detailed Description
The present study seeks to collect pilot data on a brief mindfulness-based cognitive-behavioral treatment to determine the feasibility of this intervention and its potential benefits. The study includes 6 total contacts, 1 visit before surgery and 3 after surgery, and 2 phone calls. The last visit will be about 6 months after surgery. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold. The research takes place at the Brigham & Women's Pain Management Center, 850 Boylston St, Chestnut Hill.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Knee Replacement
Keywords
CBT

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All participants will undergo quantitative sensory testing, physical functioning testing, and pain-related outcomes assessment. Participants in the intervention arm will undergo brief mindfulness-based cognitive behavioral sessions.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based CBT
Arm Type
Experimental
Arm Description
All participants will receive four individual mindfulness-based CBT sessions.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
All participants will undergo surgery as usual, with no additional intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Cognitive Behavioral Therapy
Intervention Description
Mindfulness-based CBT methods are based on pain self-management paradigms, and involve the identification and reduction of maladaptive pain-related cognitions (i.e., catastrophizing), the enhancement of self-efficacy for managing pain, and training in the use of adaptive pain-coping strategies such as relaxation, distraction, and self-talk.
Primary Outcome Measure Information:
Title
Brief Pain Inventory (BPI)
Description
Measure of pain severity and pain interference
Time Frame
baseline
Title
Brief Pain Inventory (BPI)
Description
Measure of pain severity and pain interference
Time Frame
6-week
Title
Brief Pain Inventory (BPI)
Description
Measure of pain severity and pain interference
Time Frame
3-months
Title
Brief Pain Inventory (BPI)
Description
Measure of pain severity and pain interference
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Quantitative Sensory Testing (QST)
Description
Measures of responses to standardized stimuli
Time Frame
baseline
Title
Quantitative Sensory Testing (QST)
Description
Measures of responses to standardized stimuli
Time Frame
3-months
Title
Pain Catastrophizing Scale
Description
Assess catastrophic thinking related to pain
Time Frame
baseline
Title
Pain Catastrophizing Scale
Description
Assess catastrophic thinking related to pain
Time Frame
6-week
Title
Pain Catastrophizing Scale
Description
Assess catastrophic thinking related to pain
Time Frame
3-months
Title
Pain Catastrophizing Scale
Description
Assess catastrophic thinking related to pain
Time Frame
6-months
Title
PROMIS-SF
Description
Measures anxiety and depression symptoms
Time Frame
baseline
Title
PROMIS-SF
Description
Measures anxiety and depression symptoms
Time Frame
6-week
Title
PROMIS-SF
Description
Measures anxiety and depression symptoms
Time Frame
3-months
Title
PROMIS-SF
Description
Measures anxiety and depression symptoms
Time Frame
6-months
Title
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Description
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
Time Frame
baseline
Title
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Description
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
Time Frame
6-week
Title
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Description
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
Time Frame
3-months
Title
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Description
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 45 or older, Meet the American College of Rheumatology criteria for knee OA, Scheduled to undergo total knee arthroplasty, Facility with the English language that is adequate to complete study procedures Exclusion Criteria: Cognitive impairment preventing completion of study assessment procedures. Myocardial infarction within the past 12 months. Presence of Severe Raynaud's or severe neuropathy, Active vasculitis or severe peripheral vascular disease, Current infection, Use of oral steroids, Recent history of substance abuse or dependence, Known anemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Edwards, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital Pain Management Center
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36394250
Citation
Pester BD, Wilson JM, Yoon J, Lazaridou A, Schreiber KL, Cornelius M, Campbell CM, Smith MT, Haythornthwaite JA, Edwards RR, Meints SM. Brief Mindfulness-Based Cognitive Behavioral Therapy is Associated with Faster Recovery in Patients Undergoing Total Knee Arthroplasty: A Pilot Clinical Trial. Pain Med. 2023 Jun 1;24(6):576-585. doi: 10.1093/pm/pnac183.
Results Reference
derived
Links:
URL
https://rally.partners.org/study/knee_replacement
Description
Local site recruitment link

Learn more about this trial

Prediction of Outcomes Following Total Knee Replacement- Pilot

We'll reach out to this number within 24 hrs